At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 32 enrolled
Drug / intervention
Arbaclofendrug
Likely dose
Arbaclofen 1mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label, Flexible-Dose Evaluation of the Safety and Tolerability of STX209 for Treatment of Irritability in Subjects With Autism Spectrum Disorders
In Brief
A Phase 2 clinical trial evaluating Arbaclofen for Autism Spectrum Disorders. Completed, enrolled 32 participants across 8 sites.
Detailed Summary
The study objective is to explore the safety and tolerability of STX209 in subjects with Autism Spectrum Disorders and to obtain preliminary data on several measures of efficacy in treating irritability. We hypothesize that STX209 will be safe and well-tolerated.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAutism Spectrum Disorders
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2009
First PostedFeb 2009
Primary CompletionJun 2010
Study CompletionSep 2010
TodayJul 2026
First PostedFeb 18, 2009
Enrollment StartFeb 1, 2009
Primary CompletionJun 1, 2010
Study CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 17.4 years ago
Interventions
Arbaclofendrug
variable dose from 1mg bid to 10 mg tid, oral capsule, 8 week treatment period